a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time. It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ConTIPI Ltd. vaginal pessary device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Objective Efficacy: ≥ 70% reduction in pad weight	94% of participants achieved > 70% reduction (p<0.001); mean reduction = 86±9%. 80% of patients had >80% reduction.
Subjective Efficacy: Participant's perception of being dry	92% considered themselves dry compared to the first week and last few days of use.
Subjective Efficacy: Leak Score Quality of Life (QoL) questionnaire reduction	Total score decreased from 21.26 (pre-trial) to 5.3 (post-trial).
Safety: Adverse events	6.6% reported adverse events, which is lower than other predicate study results.
Biocompatibility	Demonstrated per ISO 10993-1.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Fifty (50) participants.
- Data Provenance: Not explicitly stated, but the company is based in Haifa, Israel, suggesting the study likely took place in Israel. The data is prospective, as it involved actively recruiting and following participants.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the summary. The study collected objective (pad weight) and subjective (participant perception, QoL questionnaire) endpoints directly from participants, rather than relying on expert interpretation of data like images or clinical signs.
Adjudication Method for the Test Set:
- None specified. For objective measures like pad weight, adjudication typically isn't required. For subjective measures, participant reporting serves as the "ground truth."
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study (MRMC) is typically conducted for diagnostic imaging devices where different readers interpret the same cases. This device is a therapeutic device, and the study focused on its direct impact on patient symptoms and quality of life.
Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
- Yes, effectively. This device is a standalone therapeutic product; it does not involve an algorithm, nor does it require human-in-the-loop interaction in the context of an AI-driven system. The "performance" measured is the direct effect of the device on the user.
Type of Ground Truth Used:
- Objective measurements (pad weight) and Subjective patient-reported outcomes (perception of dryness, Quality of Life questionnaire).
Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The 50-participant study served as the primary clinical validation for regulatory submission.
How the Ground Truth for the Training Set was Established:
- Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this device.

Summary

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K060524
page 1 of 2

510(k) Summary

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 15-May-06

JUN - 9 2006

ConTIPI Ltd.
99 Hahistadrut Ave.	Tel - 011-972-4-8470113
Haifa 31250 ISRAEL	Fax - 011-972-4-8490824

Official Contact --	Nir Sinai - Project Manager
Proprietary or Trade Name -
Common/Usual Name -	Intra-vaginal stress incontinence device
Classification Name --	Vaginal pessary
Device --
Predicate Devices --	Johnson & Johnson - Introl ® - Bladder Neck Support K930618 and K965040

JUN - 6 2002Device Description --

It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.

Indications for Use --	indicated for temporary management of genuine (mild, moderate and severe) stress urinary incontinence in females.
Patient Population --	designed to be used by any woman, who suffers from stress urinary incontinence.
Environment of Use --	No limitations

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1K060526
Page 1 of 2

Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 15-May-06

Contraindications --	Patients should not use if:
	Vaginal infection or lacerations are present Urinary tract infections Severely atrophic vagina Recovering from recent vaginal surgery Have difficulty inserting a vaginal tampon

Abnormal vaginal bleeding .
During monthly menstruation period .
During coitus .
Consult your doctor regarding use during pregnancy ◆

Clinical Testing Effectiveness and Safety --

A fifty (50) participant safety and efficacy study was performed. It measured objective and subjective end-points.

Objective Efficacy end-point

Reduction in pad weight Objective at least a 70% reduction .
- 94% of participants obtained % reduction of over 70% (p<0.001), mean % reduction . 86±9% (with high range of 59-98%), and a specific frequency distribution showed that 80% of patients had >80% reduction of A pad weight.

Subjective Efficacy end-points

Participant's perception of being dry .
. 92% considered themselves dry when compared to the first week and the last few days of use
Leak Score Quality of Life (QoL) questionnaire the total score, decreasing from 21.26 to ● 5.3, pre-trial vs. post-trial, respectively.

Safety Testing

We monitored all participants for any problems and adverse events. ●
. The number of reported adverse events was 6.6% which is lower than other predicate study results.
Biocompatibility testing per ISO 10993-1 has been demonstrated. .

Substantial Equivalence -

The device based upon a comparison to the predicate and clinical testing has been demonstrated that it is substantially equivalent.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 9 2006

ConTIPI Ltd. % Mr. Paul E. Dryden Regulatory Consultant ProMedic. Incorporated 6329 W. Waterview Ct. MCCORDSVILLE IN 46055-9501

Re: K060526

Trade/Device Name: Vaginal Pessary Regulation Number: 21 CFR § 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: May 15, 2006 Received: May 16, 2006

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The seal also includes the years "1906-2006" and the phrase "Protecting and Promoting Public Health" written in cursive. The logo is black and white.

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number: K060526

Device Name:

Indications for Use:

Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.

Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Vaginal Pessary device

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).